Clinical Trials

 Inclustion Criteria:

1. Patients must have a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity.
2. Patients between the ages of 6 and 65, inclusive, at the time of signing Informed Consent or Assent are eligible for the study.
3. Obese, defined as BMI ≥40 kg/m2 for patients ≥18 years of age or BMI ≥97th percentile for age and gender for patients 6 up to <17 years of age based on the United States (US) Centers for Disease Control and Prevention criteria.
4. Study participant and/or parent or guardian is able to communicate well with the Investigator, to understand and comply with the requirements of the study (including QD injection regimen and all other study procedures) and is able to understand and sign the written informed consent/assent. Patients who are unable to comply with all study procedures due to cognitive limitations or any other reason should not be enrolled into the study.
5. If male or a childbearing female, including pre-pubertal females if relevant, agrees to use a highly reliable form of contraception throughout the study and for 90 days following the study.

Exclusion Criteria:

1. Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that has resulted in >3% weight loss.
2. Use of any medication that is approved to treat obesity within 3 months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).
3. Bariatric surgery within the previous 6 months.
4. Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s) that the Investigator believes will interfere significantly with study compliance.
5. Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) during Screening, any suicide attempt in the past 20 years or any suicidal behavior in the last month.
6. Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results. Any patient with a potentially clinically significant disease should be reviewed with the Sponsor to determine eligibility.
7. Has significant features of (or meets the diagnostic criteria for) a genetic syndrome that is associated with obesity, such as Tatton-Brown-Rahman syndrome (DNMT3A), Rett Syndrome (MECP2), Chung-Jansen syndrome (PHIP), Schaaf-Yang syndrome (MAGEL2), ulnar mammary syndrome (TBX3), or Rubinstein-Taybi syndrome (CREBBP).
8. Glycated hemoglobin (HbA1C) >10.0% at Screening.
9. History of significant liver disease other than non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
10. Glomerular filtration rate (GFR) <60 mL/min at Screening.
11. History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism. (Note: If the type of skin cancer is not known, then the patient should not be enrolled into the study.)
12. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion), determined as part of a comprehensive skin evaluation performed by the Investigator during Screening. Any concerning lesions identified during Screening will be biopsied and results known to be benign prior to enrollment. If the pretreatment biopsy results are of concern, the patient may need to be excluded from the study.
13. Patient is, in the opinion of the Investigator, not suitable to participate in the study.
14. Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
15. Patients previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
16. Significant hypersensitivity to any excipient in the study drug.
17. Females who are breastfeeding or nursing.